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Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Older people's experiences of elder abuse in residential care settings: A scoping review

Abstract

Background

Elder abuse is a global human rights issue, particularly in residential care settings where there is limited understanding of older people's experiences of this phenomenon. This scoping review aims to map and describe the existing literature on this phenomenon.

Methods

Using Arksey and O'Malley's scoping review methodology, further developed by Levac et al. and the Joanna Briggs Institute, a systematic search of six databases was conducted to identify relevant studies published from inception to January 2023. Studies were included if they focused on older people's experience of abuse within residential care settings. A comprehensive data extraction process was employed to identify key themes from the included studies.

Results

The initial search yielded a total of 3701 articles of which eight met the inclusion criteria. The findings revealed a range of abusive experiences encountered by older people living in residential care settings, including psychological, physical, financial, neglect and sexual abuse. The common attributes of residents vulnerable to abuse were evident throughout each of the studies. Finally, the theme of organizational neglect was apparent through the absence of effective safeguarding measures in the included studies. The findings revealed the insufficient implementation of safeguarding measures increases the risk of abuse among residents.

Conclusion

This scoping review highlights the limited research on the experiences of older people who have encountered elder abuse in residential care settings. The findings stress the need for further research exploring the complex interplay of factors contributing to elder abuse within aged care settings. The insights gained from this scoping review can inform the development of comprehensive safeguarding strategies to prevent and address elder abuse in residential care settings, promoting the well-being and safety of older people.

Patient or Public Contribution

This project is a scoping review of the literature; therefore, no patient or public contribution was deemed necessary.

What this paper contributes to the wider global community

Most research on elder abuse has been conducted in the community rather than in Residential Care Settings where there is a limited understanding of older people’s experiences of abuse within the published literature. The scoping review highlights the presence of inadequate safeguarding strategies in Residential Care Settings within the reviewed studies, providing recommendations for developing and improving safeguarding measures in Residential Care Settings to prevent abuse, neglect, and harm in the future.

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